Infusion adapter for drug transfer assembly

ABSTRACT

An infusion adapter for connection with an infusion fluid container includes a connection portion including an anchor component for connecting to an injection port of the infusion fluid container, and a first port adapted for connection with a syringe assembly containing a medication fluid. The first port is in fluid communication with the connection portion. The anchor component is configured to securely connect the infusion adapter to the infusion fluid container to substantially prevent disconnection of the infusion adapter from the infusion fluid container once the infusion adapter is connected to the infusion fluid container.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. application Ser.No. 14/091,506, filed Nov. 27, 2013, which claims priority to U.S.Provisional Application Ser. No. 61/731,902, filed Nov. 30, 2012, whichis hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to a drug transfer assembly.More particularly, the present disclosure relates to an anchor componentfor securely connecting an infusion adapter to an intravenous bag for adrug transfer procedure.

2. Description of the Related Art

Intravenous therapy applications allow patients to receive infusion andmedication treatment. For example, therapy may include theadministration of medications by IV using intravenous and subcutaneousor hypodermis routes, i.e., into the bloodstream and under the skin.Examples of medical treatments that intravenous therapy applications mayprovide to a patient include antibiotics, pain management medications,cancer treatments, and similar medications.

Medications may be packaged as “pre-filled” devices, wherein a syringeassembly is pre-filled with medication prior to being packaged anddelivered to a patient. “Pre-filled” devices eliminate the need for auser to fill the device prior to injection.

Certain drugs or medications are preferably provided in powder or dryform (such as a lyophilized form), and require reconstitution prior toadministration. Lyophilized drugs, for example, typically are suppliedin a freeze-dried form that needs to be mixed with a diluent toreconstitute the substance into a form that is suitable for injection.In addition, drugs may be provided as multipart systems that requiremixing prior to administration. For example, one or more liquidcomponents, such as flowable slurries, and one or more dry components,such as powdered or granular components, may be provided in separatecontainers that require mixing prior to administration.

A patient may be provided with an intravenous system that includesintravenous tubing and a connector that is adapted to receive aninjector and/or syringe assembly containing a required medication. Inthis manner, when a treatment is needed, a patient or a medicalpractitioner is able to connect a syringe assembly to the connector andthen inject a medication intravenously into the patient via the injectorand/or syringe assembly, the connector, and the intravenous tubing.

When performing infusion, it is often necessary to inject a drug orother medical substance into the infusion fluid inside an infusion bagor other infusion fluid container. This is often done by means ofpenetrating a septum or other fluid barrier of an injection port on theinfusion bag or on the infusion fluid line with a needle of a syringefilled with the medical fluid in question. However, it has been foundthat an unsecure connection between the syringe and the injection portof the infusion bag may cause problems such as accidental or inadvertentdisconnection of the syringe from the infusion bag, pollution of theworking environment because of leakage, and high forces required topierce a fluid barrier of the injection port of the infusion bag.

SUMMARY OF THE INVENTION

In one embodiment, an infusion adapter for connection with an infusionfluid container includes a connection portion including an anchorcomponent for connecting to an injection port of the infusion fluidcontainer, and a first port adapted for connection with a syringeassembly containing a medication fluid. The first port is in fluidcommunication with the connection portion. The anchor component isconfigured to securely connect the infusion adapter to the infusionfluid container to substantially prevent disconnection of the infusionadapter from the infusion fluid container once the infusion adapter isconnected to the infusion fluid container.

The infusion adapter may further include a second port adapted forconnection with an intravenous line adapted for connection to abloodstream of a patient with the second port in fluid communicationwith the connection portion. The anchor component may be a helicalthread. The helical thread may extend about an entire length of theconnection portion. The helical thread may only extend one revolutioncircumferentially around the connection portion. The anchor componentmay reduce a force required by a user to pierce a fluid barrier memberof the injection port of the infusion fluid container. The connectionportion may define first and second fluid channels with the firstchannel in fluid communication with the first port and the secondchannel in fluid communication with the second port. The connectionportion may be a spike having a puncturing point. The helical thread maybe configured to self-tap a corresponding thread within a portion of theinfusion fluid container when the connection portion is received by theinfusion fluid container.

In another embodiment, an adapter for connection with a containerincludes a connection portion configured to be connected to a firstcontainer with the connection portion including a helical thread. Theadapter further includes at least one port adapted to be connected to asecond container with the connection portion configured to be in fluidcommunication with the at least one port. The connection portion and thehelical thread are configured to be received by a portion of the firstcontainer with the helical thread configured to securely connect theconnection portion to the first container once the connection portion isconnected to the first container.

The helical thread may extend about an entire length of the connectionportion. The helical thread may only extend one revolutioncircumferentially around the connection portion. The helical thread mayreduce a force required by a user to pierce a fluid barrier member ofthe first container. The at least one port may include first and secondports with the first port configured to be connected with the secondcontainer and the second port configured to be connected with a thirdcontainer. The connection portion may define first and second fluidchannels with the first channel in fluid communication with the firstport and the second channel in fluid communication with the second port.The connection portion may be a spike having a puncturing point. Thehelical thread may be configured to self-tap a corresponding threadwithin a portion of the first container when the connection portion isreceived by the first container.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of an infusion adapter in accordance withan embodiment of the present invention.

FIG. 2 is another perspective view of the infusion adapter of FIG. 1 inaccordance with an embodiment of the present invention.

FIG. 3 is a perspective view of an intravenous line connector of theinfusion adapter of FIG. 1 in accordance with an embodiment of thepresent invention.

FIG. 4 is a perspective view of a main body of the infusion adapter ofFIG. 1 with the intravenous line connector of FIG. 3 removed inaccordance with an embodiment of the present invention.

FIG. 5 is a side view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 6 is a top view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 7 is a rear view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 8 is a bottom view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 9 is a side view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 10 is a front view of the infusion adapter of FIG. 1 in accordancewith an embodiment of the present invention.

FIG. 11 is a cross-sectional view taken along line 11-11 of the infusionadapter of FIG. 5 in accordance with an embodiment of the presentinvention.

FIG. 12 is a cross-sectional view of the infusion adapter of FIG. 1 withan anchor component of the connection portion of the infusion adapteranchored and securely connected to an injection port of an infusionfluid container in accordance with an embodiment of the presentinvention.

FIG. 13 is a cross-sectional view of the infusion adapter of FIG. 1 withan anchor component of the connection portion of the infusion adapteranchored and securely connected to an injection port of an infusionfluid container, with a syringe assembly containing a medication fluidconnected to a first port of the infusion adapter via a connector, andwith an intravenous line connected to a second port of the infusionadapter, the intravenous line connected at an opposite end to abloodstream of a patient in accordance with an embodiment of the presentinvention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

Referring to FIGS. 1-13, an infusion adapter 10 includes a connectionportion 12 located at a first end 14, a first port 16 located at a firstport end 18, and a second port 20 located at a second port end 22.Connection portion 12 includes an anchor component 24 and a fluidchannel 26 and a fluid channel 32, although only a single channelarrangement may also be utilized. First port 16 includes a first portfluid channel 28 and second port 20 includes a second port fluid channel30. As shown more clearly in FIGS. 12 and 13, the fluid channel 26 ofconnection portion 12 is in fluid communication with first port fluidchannel 28 of first port 16 such that a fluid may flow into infusionadapter 10 at first port 16, travel through first port fluid channel 28to fluid channel 26 of connection portion 12 and out first end 14 ofinfusion adapter 10. The fluid channel 32 of connection portion 12 is influid communication with second port fluid channel 30 of second port 20such that a fluid may flow into infusion adapter 10 at first end 14 ofconnection portion 12, travel through fluid channel 32 to second portfluid channel 30 and out second port 20 of infusion adapter 10.

Referring to FIGS. 1-13, in one embodiment, infusion adapter 10 maycomprise a generally Y-shape. Further, it is contemplated that infusionadapter 10 may be made available in a variety of shapes and sizes aslong as first port 16 is spaced a distance from second port 20 so thatfirst port 16 may be connected to a syringe assembly containing amedication fluid and second port 20 may be connected to an intravenousline that is adapted for connection to a bloodstream of a patient aswill be described in more detail below. For example, in anotherembodiment, infusion adapter 10 may comprise a generally T-shape.

Referring to FIGS. 3 and 4, in one embodiment, infusion adapter 10 mayinclude an intravenous line connector 34 (FIG. 3) that is removablyconnectable to a main body 36 (FIG. 4) of infusion adapter 10. In suchan embodiment, main body 36 includes an intravenous line connectorreceiving end 38 having a first connection portion 40 as shown in FIG.4. Additionally, intravenous line connector 34 includes a main bodyreceiving end 42 having a second connection portion 44 as shown in FIG.3. Referring to FIG. 3, intravenous line connector 34 includes an endcap 46 that is pivotable via a hinge portion 48 between an open position(FIG. 3) to a closed position.

Intravenous line connector 34 may be connected to main body 36 bypositioning main body receiving end 42 of intravenous line connector 34into engagement with intravenous line connector receiving end 38 of mainbody 36. In one embodiment, intravenous line connector 34 may be securedto main body 36 by positioning second connection portion 44 ofintravenous line connector 34 into engagement with first connectionportion 40 of main body 36, and threadingly engaging first connectionportion 40 and second connection portion 44. In other embodiments,second connection portion 44 of intravenous line connector 34 may besecured to first connection portion 40 of main body 36 using apress-fit, locking tapers, interference fit, snap-fit, ball detent,locking tabs, spring loaded locking mechanism, latch, adhesive, or othersimilar mechanism. In this manner, intravenous line connector 34 islocked to main body 36, i.e., significant relative movement betweenintravenous line connector 34 and main body 36 is prevented. Inalternate embodiments, intravenous line connector 34 and main body 36may be integrally formed.

Referring to FIGS. 1-13, connection portion 12 of infusion adapter 10includes anchor component 24 and a puncturing point 60 disposed adjacentfirst end 14. In one embodiment, anchor component 24 includes a helicalthread 50 which forms a threaded spike 52. The helical thread 50 extendsradially outward from the connection portion 12 and extends about thefull length of the connection portion 12. The helical thread 50 has twoflank portions and a crest portion that is flat, although any othersuitable thread form may be utilized. The starting and ending point ofthe helical thread 50 may be tapered to form a gradual beginning and endto the helical thread 50. As shown in FIG. 1, the helical thread 50extends circumferentially once around the connection portion 12 (360degrees or one revolution), although any other suitable thread pitchesmay be utilized. Further, although a single helical thread 50 isutilized, the anchor component 24 may include one or more helicalthreads 50. The helical thread 50 allows for anchor component 24 toengage and interface the interior walls of an injection port 104 whenconnecting infusion adapter 10 to an infusion fluid container 102. Inone embodiment, the thread 50 may self-tap and cut its own thread in theinterior walls of injection port 104. In this manner, connection portion12 of infusion adapter 10 is locked and anchored within injection port104, i.e., significant relative movement between infusion adapter 10 andinjection port 104 of infusion fluid container 102 is prevented anddisconnection of infusion adapter 10 from the infusion fluid container102 is prevented. In an alternative embodiment, threaded spike 52 ofconnection portion 12 of infusion adapter 10 may threadingly engagecorresponding threads located on the interior walls of injection port104 of infusion fluid container 102.

Referring to FIGS. 12 and 13, anchor component 24 provides a means forconnecting first end 14 of infusion adapter 10 to an injection port 104of an infusion fluid container 102. With the anchor component 24 ofconnection portion 12 connected to injection port 104 of the infusionfluid container 102, the anchor component 24 securely connects infusionadapter 10 to the infusion fluid container 102 such that disconnectionof infusion adapter 10 from the infusion fluid container 102 isprevented. Additionally, anchor component 24 of connection portion 12anchors infusion adapter 10 to injection port 104 of infusion fluidcontainer 102, i.e., significant relative movement between infusionadapter 10 and injection port 104 of infusion fluid container 102 isprevented. In this manner, anchor component 24 prevents inadvertent andaccidental removal of infusion adapter 10 from infusion fluid container102 and provides a leakproof connection between infusion adapter 10 andinfusion fluid container 102 during a drug transfer procedure.Furthermore, anchor component 24 reduces the spiking force required topierce a fluid barrier member 106 of injection port 104 of the infusionfluid container 102. In particular, the connection portion 12 engagesthe injection port 104 and is rotated such that the helical thread 50engages the interior surface of the injection port 104 thereby providinga mechanical advantage to pierce the fluid barrier member 106 and tofully insert the connection portion 12 within the injection port 104.Infusion fluid container 102 may also include a second port 108 andsecond fluid barrier 110.

In one embodiment, infusion adapter 10 comprises a PhaSeal adapter whichis compatible with a Becton Dickinson (“BD”) PhaSeal™ System availablefrom Becton, Dickinson and Company of Franklin Lakes, N.J.

As previously discussed, intravenous therapy applications allow patientsto receive infusion and medication treatment. For example, therapy mayinclude the administration of medications by IV using intravenous andsubcutaneous or hypodermis routes, i.e., into the bloodstream and underthe skin. Examples of medical treatments that intravenous therapyapplications may provide to a patient include antibiotics, painmanagement medications, cancer treatments, and similar medications.

Referring to FIG. 13, a patient may be provided with a fluid transfersystem 100 that includes intravenous tubing 120 and a connector orinjector adapter member 130 that is adapted to receive an injectorand/or syringe assembly 140 containing a required medication fluid 142.

When performing infusion, it is often necessary to inject a drug orother medical substance into an infusion fluid 112 located inside aninfusion bag or other infusion fluid container 102. This is often doneby means of penetrating a septum or fluid barrier member 106 of aninjection port 104 on the infusion fluid container 102.

Referring to FIGS. 12 and 13, when a treatment is needed, a patient or amedical practitioner is able to spike or pierce fluid barrier member 106of injection port 104 of infusion fluid container 102 with puncturingpoint 60 and anchor component 24 of connection portion 12 of infusionadapter 10. Advantageously, anchor component 24 of infusion adapter 10in accordance with the present disclosure locks and anchors connectionportion 12 of infusion adapter 10 within injection port 104, i.e. ,significant relative movement between infusion adapter 10 and injectionport 104 of infusion fluid container 102 is prevented and disconnectionof infusion adapter 10 from the infusion fluid container 102 isprevented as previously discussed.

With infusion adapter 10 securely connected to injection port 104 ofinfusion fluid container 102 via anchor component 24, a patient or amedical practitioner is able to connect syringe assembly 140 to firstport 16 of infusion adapter 10. In one embodiment, a medicalpractitioner is able to connect syringe assembly 140 to first port 16 ofinfusion adapter 10 via connector 130 as shown in FIG. 13. Connector 130could be a piercing member protection connector in accordance with theconnector and protection device described in U.S. Pat. No. 8,075,550,filed Jul. 1, 2008, entitled “Piercing Member Protection Device”, theentire disclosure of which is hereby expressly incorporated herein byreference.

With syringe assembly 140 connected to first port 16, a medication fluid142 contained in syringe assembly 140 can be injected into the infusionfluid container 102 via infusion adapter 10. The syringe assembly 140and connector 130 may then be disconnected from infusion adapter 10 andthe infusion fluid container 102 may then be sent to nursing and isready to be administered to a patient. For example, an intravenous lineor intravenous tubing 120 may be connected to second port 20 of infusionadapter 10 as shown in FIG. 13. The other end of the intravenous tubing120 is connected to a bloodstream of a patient P as shown in FIG. 13. Inthis manner, a medication may be administered to the patientintravenously.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. An infusion adapter for connection with aninfusion fluid container, the infusion adapter comprising: a connectionportion including an anchor component for connecting to an injectionport of the infusion fluid container, the connection portion comprisinga spike extending from a proximal end to a puncturing point and theanchor component further comprising at least one protrusion extendingradially outward from the spike, and a circumferential path of the atleast protrusion extending axially from the proximal end of the spiketoward the distal end of the spike; a first port adapted for connectionwith a syringe assembly containing a medication fluid, the first port influid communication with the connection portion via a first passagewayextending from the first port to a distal opening positioned adjacent tothe puncturing point of the spike; and a second port adapted forconnection with an intravenous line, the second port in fluidcommunication with the connection portion via a second passagewayextending from the second port to a distal opening, the distal openingof the second passageway axially spaced from the distal opening of thefirst passageway, wherein the distal openings of the first passagewayand the second passageway are radially opposed at the distal end of thespike, and wherein the at least one protrusion of the spike isconfigured to interfere with the injection port of the infusion fluidcontainer to substantially prevent disconnection of the infusion adapterfrom the infusion fluid container once the infusion adapter is connectedto the infusion fluid container.
 2. The infusion adapter of claim 1,wherein the at least one protrusion only extends one revolutioncircumferentially around the connection portion.
 3. The infusion adapterof claim 1, wherein the anchor component reduces a force required by auser to pierce a fluid barrier member of the injection port of theinfusion fluid container.
 4. The infusion adapter of claim 1, whereinthe at least one protrusion is configured to self-tap a correspondingpathway within an internal diameter of the injection port when the spikeis inserted into the injection port.
 5. An adapter for connection with acontainer, the adapter comprising: a connection portion configured to beconnected to a first container, the connection portion including aradial protrusion; and at least one port adapted to be connected to asecond container, the connection portion configured to be in fluidcommunication with the at least one port, wherein the connection portionand the radial protrusion are configured to be received by a portion ofthe first container with the protrusion configured to securely connectthe connection portion to the first container once the connectionportion is connected to the first container, wherein the radialprotrusion extends both radially and axially along a circumference ofthe connection portion, and wherein the radial protrusion only extendsone revolution circumferentially around the connection portion, andwherein the radial protrusion is configured to deform an internaldiameter within at least a portion of the first container when theconnection portion is received by the first container.
 6. The adapter ofclaim 5, wherein the radial protrusion reduces a force required by auser to pierce a fluid barrier member of the first container.
 7. Theadapter of claim 5, wherein the at least one port comprises first andsecond ports, the first port configured to be connected with the secondcontainer, the second port configured to be connected with a thirdcontainer.
 8. The adapter of claim 7, wherein the connection portiondefines first and second fluid channels, the first channel in fluidcommunication with the first port, the second channel in fluidcommunication with the second port.
 9. The adapter of claim 5, whereinthe connection portion comprises a spike having a puncturing point.